The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Nexus Drf Digital X-ray Imaging System.
| Device ID | K103416 |
| 510k Number | K103416 |
| Device Name: | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | INFIMED, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah INFIMED, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854344007078 | K103416 | 000 |